||June 21, 2013
||MAQUET GETINGE GROUP Arterial Cannula OD
Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
||Catalogue Number:Part Number: Lot Number are as follows:
(1) 161410 (10 FR.):701022682:92056588 (2) 163610 (10 Fr):70102597:92059789 (3) 163608 (8 Fr.):70102.2681:92065640 (4) 163606 (6 Fr.):70102.2680:92063566
|Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
|For Additional Information Contact
||Ms. Whitney Torning
|The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
||Maquet sent an "Urgent Product Recall"/"Recall - Device Corrective Action Response" forms dated May 14, 2013, via Federal Express to all affected customers. The notification identifies affected product; informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; and advises customers to follow instructions on the "Recall-Device Corrective Action Response" forms included as part of the notification.
If you have any further questions please contact your local MAQUET representative or call Customer Service at (888) 627-8383.
|Quantity in Commerce
||100 units (60 Domestic; 40 International)
||Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.